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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003315-21 | EudraCT Number |
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The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
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This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06755347 intravenous healthy participant | Experimental | intravenous administration |
|
| Placebo intravenous healthy participant | Placebo Comparator | intravenous administration |
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| PF-06755347 subcutaneous healthy participant | Experimental | subcutaneous administration |
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| Placebo subcutaneous healthy participant | Placebo Comparator | subcutaneous administration |
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| PF-06755347 subcutaneous ITP | Experimental | subcutaneous |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06755347 intravenous healthy participant | Drug | Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs. | Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts). |
| Number of Participants With Laboratory Test Abnormalities | Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported. | Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. |
| Number of Participants With Vital Signs Meeting Categorical Criteria | Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) <50 mmHg; pulse rate <40 beats per minute (bpm); pulse rate >120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | Cmax was the highest concentration observed directly from data | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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Inclusion Criteria Healthy male participants:
Exclusion Criteria for Healthy male participants:
Female participants may be of childbearing potential or non-childbearing potential.
-Diagnosis of Primary ITP. ITP must be diagnosed in accordance with established guidelines. ITP duration-Persistent (>3 months and ≤12 months) OR Chronic (>12 months).
AND
Platelet count 30-75 x 10E9/L (inclusive) with criteria achieved on 2 qualifying counts at least 5 days apart and within approx. 10 days of dosing
Participants must have received and responded to IVIg or corticosteroids as treatment for ITP (response is defined as achievement of platelet count >50 x 109/L and doubling of platelet count from baseline).
--Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
BMI of 17.5 to 30.5 kg/m2 and a total body weight >40 kg (88 lbs).
Exclusion Criteria for ITP participants
Chest x-ray must be taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Clinical Research Unit |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The study planned 14 cohorts, however, it was terminated due to non-safety reasons during Cohort 11, with no further enrollment. Included in this study were all healthy participants, who were randomized to either receive PF-06755347 or placebo by intravenous (IV) or subcutaneous (SC) administration in a 3:1 allocation ratio. A total of 58 participants were dosed in this study: 42 received PF-06755347 and 16 received placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: PF-06755347 0.01 mg/kg IV | Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1. |
| FG001 | Cohort 2: PF-06755347 0.03 mg/kg IV | Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2022 | Jan 5, 2024 |
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single ascending dose study
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Double blind (investigator and subject), sponsor open in healthy male participants. Masking will not be applied for participants with ITP (all ITP participants will receive PF-06755347).
| Placebo intravenous healthy participant | Drug | Placebo comparator |
|
| PF-06755347 subcutaneous healthy participant | Drug | single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5. |
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| Placebo subcutaneous healthy participant | Drug | placebo comparator |
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| PF-06755347 subcutaneous ITP | Drug | single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants |
|
| Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. |
| Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to <480 msec; QTcF interval ≥480 to <500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline >200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: >30 to ≤60 msec; QTcF interval change from baseline >60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1. | Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts). |
| Cmax of PF-06755347 Following Single SC Dose |
Cmax was the highest concentration observed directly from data |
| Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | Cmax(dn) = Cmax/Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| Cmax(dn) of PF-06755347 Following Single SC Dose | Cmax(dn) = Cmax/Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| Tmax of PF-06755347 Following Single SC Dose | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | AUClast was determined using linear/Log trapezoidal method | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| AUClast of PF-06755347 Following Single SC Dose | AUClast was determined using linear/Log trapezoidal method | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | AUClast(dn) = AUClast/Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| AUClast(dn) of PF-06755347 Following Single SC Dose | AUClast(dn) = AUClast/Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| AUCinf of PF-06755347 Following Single SC Dose | AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | AUCinf(dn) = AUCinf/Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| AUCinf(dn) of PF-06755347 Following Single SC Dose | AUCinf(dn) = AUCinf/Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| t½ of PF-06755347 Following Single SC Dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Clearance (CL) of PF-06755347 Following Single IV Dose | CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug. | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
| Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
| Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1. | Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts |
| Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
| Brussels |
| B-1070 |
| Belgium |
| NZCR (New Zealand Clinical Research) OPCO Limited | Christchurch | 8011 | New Zealand |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hammersmith Medicines Research (HMR) | London | NW10 7EW | United Kingdom |
| FG002 | Cohort 3: PF-06755347 0.1 mg/kg IV | Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. |
| FG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| FG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| FG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| FG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| FG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| FG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| FG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| FG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| FG011 | Placebo | Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: PF-06755347 0.01 mg/kg IV | Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1. |
| BG001 | Cohort 2: PF-06755347 0.03 mg/kg IV | Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1. |
| BG002 | Cohort 3: PF-06755347 0.1 mg/kg IV | Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. |
| BG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| BG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| BG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| BG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| BG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| BG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| BG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| BG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| BG011 | Placebo | Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs. | All participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts). |
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| Primary | Number of Participants With Laboratory Test Abnormalities | Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported. | All participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. |
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| Primary | Number of Participants With Vital Signs Meeting Categorical Criteria | Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) <50 mmHg; pulse rate <40 beats per minute (bpm); pulse rate >120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1. | All participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. |
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| Primary | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to <480 msec; QTcF interval ≥480 to <500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline >200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: >30 to ≤60 msec; QTcF interval change from baseline >60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1. | All participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts). |
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| Secondary | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | Cmax was the highest concentration observed directly from data | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (ug/mL) | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | Cmax of PF-06755347 Following Single SC Dose | Cmax was the highest concentration observed directly from data | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | Cmax(dn) = Cmax/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL/(miligrams/kilogram [mg/kg]) | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | Cmax(dn) of PF-06755347 Following Single SC Dose | Cmax(dn) = Cmax/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL/(mg/kg) | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Median | Full Range | hours | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | Tmax of PF-06755347 Following Single SC Dose | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Median | Full Range | hours | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | AUClast was determined using linear/Log trapezoidal method | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (ug*hr/mL) | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | AUClast of PF-06755347 Following Single SC Dose | AUClast was determined using linear/Log trapezoidal method | All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | AUClast(dn) = AUClast/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL/(mg/kg) | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | AUClast(dn) of PF-06755347 Following Single SC Dose | AUClast(dn) = AUClast/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL/(mg/kg) | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | AUCinf of PF-06755347 Following Single SC Dose | AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | AUCinf(dn) = AUCinf/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL/mg | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | AUCinf(dn) of PF-06755347 Following Single SC Dose | AUCinf(dn) = AUCinf/Dose | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL/mg | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Mean | Standard Deviation | hours | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | t½ of PF-06755347 Following Single SC Dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Mean | Standard Deviation | hours | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Clearance (CL) of PF-06755347 Following Single IV Dose | CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug. | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr/kg | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. |
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| Secondary | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1. | All participants who received at least 1 dose of study medication. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure. | Posted | Count of Participants | Participants | Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts |
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| Secondary | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled participants treated who had at least 1 measurement of the exploratory endpoints of interest. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure. | Posted | Mean | Standard Deviation | nanograms per liter (ng/L) | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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| Secondary | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe. | Posted | Mean | Standard Deviation | ng/L | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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| Secondary | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe. | Posted | Mean | Standard Deviation | ng/L | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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| Secondary | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe. | Posted | Mean | Standard Deviation | micrograms per liter (mcg/L) | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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| Secondary | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe. | Posted | Mean | Standard Deviation | mcg/L | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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| Secondary | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. | All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. |
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Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: PF-06755347 0.01 mg/kg IV | Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Cohort 2: PF-06755347 0.03 mg/kg IV | Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Cohort 3: PF-06755347 0.1 mg/kg IV | Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG011 | Placebo | Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. | 0 | 16 | 0 | 16 | 10 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Body temperature | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Electrocardiogram PR prolongation | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Penile erythema | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Perineal swelling | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
The study was terminated due to sponsor's business decision.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2017 | Jan 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| 26-35 years |
|
| 36-45 years |
|
| 46-55 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Hispanic or Latino |
|
| Serious TEAEs |
|
| Treatment-related TEAEs |
|
| Discontinuations from study due to TEAEs |
|
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
| OG002 | Cohort 3: PF-06755347 0.1 mg/kg IV | Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. |
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
| OG002 | Cohort 3: PF-06755347 0.1 mg/kg IV | Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. |
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 |
| Cohort 4: PF-06755347 0.3 mg/kg IV |
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| Cohort 4: PF-06755347 0.3 mg/kg IV |
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| Cohort 4: PF-06755347 0.3 mg/kg IV |
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| Cohort 4: PF-06755347 0.3 mg/kg IV |
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. |
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
| OG003 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| Cohort 4: PF-06755347 0.3 mg/kg IV |
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
| Cohort 10: PF-06755347 200 mg SC |
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
|
|
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
| OG003 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG004 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
|
|
| OG003 | Cohort 4: PF-06755347 0.3 mg/kg IV | Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. |
| OG004 | Cohort 5: PF-06755347 1 mg/kg IV | Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. |
| OG005 | Cohort 6: PF-06755347 0.7 mg/kg IV | Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. |
| OG006 | Cohort 7: PF-06755347 25 mg SC | Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. |
| OG007 | Cohort 8: PF-06755347 50 mg SC | Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. |
| OG008 | Cohort 9: PF-06755347 100 mg SC | Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. |
| OG009 | Cohort 10: PF-06755347 200 mg SC | Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. |
| OG010 | Cohort 11: PF-06755347 300 mg SC | Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. |
| OG011 | Placebo | Healthy subjects received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. |
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